1. Field of the Invention
This invention relates generally to a method for assuring drug and drug product identity as a product is distributed from the manufacturer to the retailer and to the patient. This invention allows for the active evasion of the counterfeiting of pharmaceutical products.
Within the distribution system of drugs and drug products, there is a need to assure drug and drug product identity. Example scenarios include the need to identify and differentiate authentic and counterfeit drug products, and a need to assure the dispensing of the correct drug product to patients from pharmacies. There also exists the need to authenticate the manufacturer of drugs after they leave the pharmacy, such as when a drug is allegedly involved in causing injury to a patient.
Drug product counterfeiting is a significant and growing world-wide problem. There are about 9 billion subscriptions filled worldwide each year; about 3 billion prescriptions are filled in USA. It has been estimated that about 10 to 50 percent of prescription drugs in certain countries of Asia, Africa, and South America may be counterfeit. The number of counterfeit drug cases being investigated by the FDA has quadrupled and includes such well known drugs as Lipitor, Procrit, Neupogen, Serostim, Zyprexa, Viagra, and Evra. Drugs are now purchased in increasing quantities over the Internet and from Canadian and Mexican pharmacies making source and drug identification even harder.
In “Combating Counterfeit Drugs: A Report of the Food and Drug Administration”, a number of different technologies to prevent counterfeiting are discussed, such as multi-pronged approaches utilizing tag technologies (e.g. track-and-trace) pedigree papers, an electronic package code (EPC), bar codes, radio frequency ID (FRID), special inks, holograms, strengthening state licensure requirements for wholesale distributors, and continuing development and implementation of secure business practices. Also discussed is requiring manufacturers to sell products only to wholesalers who only directly purchase from the manufacturer and requiring manufacturers to publish the names of their wholesalers on their Web sites
In addition to problems of counterfeiting, with the increasing number of prescriptions being filled, there is an increased chance for prescription error. While these errors may take many forms, the likelihood of a dangerous or life threatening “adverse drug event” increases proportionally with the increased chance of prescription fill error. Several studies have shown that prescription error rates are consistently in the 2% to 7% range, with a 4% error rate often cited as a reliable average.
Many systems have been devised to apply identifying markers to drugs, such as color, size and shape distinctions among different drugs or on the same drug from different manufacturers. Identification markers applied to drugs are typically discernible to a prospective counterfeiter and can therefore be reproduced by the counterfeiter in many cases.
One of the problems confronting marking systems relating to drugs is the need to provide unadulterated drugs, i.e. drugs which the FDA considers to be subject to federal guidelines and which meet those guidelines. Thus, the addition of marker substances to a dosage form, although not discernable without sophisticated analysis procedures, must meet regulatory approval and is typically subject to onerous reporting requirements. Furthermore, counterfeiters can also analyze the drug for the presence of the marker and thereafter duplicate the marker containing drug.
Thus, there exists an unfulfilled need for a drug identification system which is covert, which is within governmental guidelines for pharmaceutical quality, which can quickly determine the source and/or identity of the drug as to manufacturer, including the production lot, and which, optionally, may be maintained in confidence from the identification system user. Ideally, the identification system is a dynamic system that changes over time, thereby rendering efforts to break the system even more unlikely to be successful.
2. Description of Related Art
Color, shape size and external markings have long been used to identify drugs in solid dosage forms to be used in conjunction with external container labeling schemes.
There are examples of overt drug labeling systems known to the art. Baum, U.S. Pat. No. 4,918,604, describes a drug labeling and prescription filing system. The system identifies the dispensed drug to be identified via a color photograph of the drug on its packaging.
An example using a combination of overt methods is disclosed in Wootton, U.S. Pat. No. 6,535,637 and entitled Pharmaceutical Pill Recognition and Verification System. The system utilizes a combination of coloration, shape, size and other surface features of the pill or tablet.
A scheme using covert identification of a drug by spectral means is disclosed in Soloman, U.S. Pat. No. 5,679,954 entitled Non-Destructive Identification of Tablet Dissolution by Means of Infared Spectroscopy and U.S. Pat. No. 5,900,634 entitled Real-Time On-Line Analysis of Organic and Non-Organic Compounds for Food, Fertilizers, and Pharmaceutical Products. Soloman provides an apparatus for infrared spectroscopy using a succession of collimated light beams throughout the middle and near infrared spectrum. These beams are impinged against the sample and the diffuse component of the reflected light is measured throughout the spectrum. Finally, the light received is analyzed by a neutral network to determine the sample characteristics.
Rzasa et al., U.S. Pat. No. 6,771,369. entitled System and Method for Pharmacy Validation and Inspection, discloses an apparatus for verifying the identity of a dispensed pharmaceutical. An analysis unit adapted to determine a property of the dispensed pharmaceutical, an input device adapted to receive predetermined identifying information corresponding to the dispensed pharmaceutical, and a comparison unit adapted to compare the determined property of the dispensed pharmaceutical with the predetermined identifying information. Rzasa et al. also discloses a method of verifying a prescription, wherein the prescription comprises a pharmaceutical compound, by associating the prescription with a unique identifier, storing the unique identifier, determining the identity of the pharmaceutical compound, and comparing the identity of the pharmaceutical compound with the unique identifier.